This paper summarises the comments that consultees made, and issues that arose during the formal consultation on the COMAH Regulations. Copies of all the comments made are available at HSE’s Information Centres in Bootle, London and Sheffield.
Five thousand copies of the consultative document (CD) reference number CD 128 were printed and all were distributed. The CD was accessed 1400 times on the Internet and over 1000 copies were downloaded. There were eight regional conferences and the COMAH proposals were presented as part of the programme at other conferences. Over 1000 people attended these events. In all just over 150 comments were received. This is small in relation to the number of CDs distributed but several of the comments were a co-ordinated response on behalf of several organisations and therefore representative of duty holders.
The CD contained a proforma for responses covering the contentious issues but consultees were free to respond in any format and any other issues surrounding implementation of COMAH that were not included in the proforma.
Details of where to obtain the Regulations and associated guidance.
The definition of existing establishment has been changed. Earlier drafts of the Regulation would have resulted in any establishment meeting the definition with only the smallest amount of dangerous substance present. They would also remain an existing establishment, able to take advantage of certain transitional arrangements. To deal with this, and a technical problem in relation to dates, the definition was amended. This new definition means that for premises to qualify as an existing establishment they must be subject to the COMAH regulations on the day the regulations come into force. In conjunction with regulation 2(6) it makes clear that any existing establishment which is not top tier COMAH on the day the regulations come into force, and later increases inventories to top tier levels will be required to produce a pre-operation safety report under regulation 7(5).
Under CIMAH, off site emergency planning fell to the Fire and Civil Defence Authorities in the former Metropolitan Counties. The level of responsibility for emergency planning changed in 1993 following the introduction of the Civil Defence (General Local Authority Functions) Regulations 1993. CIMAH was not amended to reflect these changes, and the consultation draft of COMAH continued the allocation of emergency planning to FCDA’s. There were two options:
The original consultation was on the basis of option 1; but following advice from the Home Office consideration was being given to option 2. Views were sought from the Local Government Association (LGA) and others. On balance the majority were in favour of retaining the original definition.
Should COMAH apply to uranium and plutonium at sites licensed under the Nuclear Installations Act?
The European Commission have confirmed that the Directive was not intended to apply to uranium and plutonium and other materials which have a dual ionising radiation hazard and toxic hazard and which are subject to other regulatory regimes that ensure safety. On this basis the Regulations have been amended.
Consultees thought that the rules for aggregating substances and discounting 2% quantities were unclear and would benefit from worked examples. More guidance would be necessary on how sites come within scope because of substances generated due to loss of control of industrial chemical processes (for example, loss of cooling in an exothermic reaction) and there should be clarification of how mixtures and preparations are dealt with.
Guidance to be amplified. Worked examples of the aggregation rules and the 2% rule to be included and guidance on mixtures and preparations to be expanded. Comments confirmed the view that predicting what substances/quantities might be generated during the loss of control of an industrial chemical process would be very difficult and in recognition of this operators will be allowed a 12 month transition period after they become aware that they can generate dangerous substances to comply with the pre-operation requirements of COMAH (for example notification, safety reports and emergency plans). Further guidance will be considered but in the meantime operators should discuss the matter with the competent authority if there is any uncertainty.
industry agreed that there should be consultation between the competent authority and operator at the pre-construction stage but there was opposition to the amount of information required and, in particular, to the hold on starting construction until the operator had the conclusions of the assessment. It was felt that operators should be able to proceed with construction at their own risk or, at least, start those aspects of construction which did not depend on detailed design having been finalised after a hazardous substances consent had been granted.
Some form of submission before construction, and retaining the hold point, is appropriate. The pre-construction safety report examines the fundamental safety and environmental design concepts of the new establishment both in relation to risks to employees (on-site) and the public (off-site). But the regulation has been redrafted to encourage submission of the pre-construction part of the safety report in a rolling programme rather than one chunk. The hold point before construction starts will be retained but the new provision will minimise delays by matching the way projects are managed and guidance will emphasise how existing information can be used in a rolling programme.
There was a large measure of agreement that COMAH safety report submissions could be phased, triggered by the date the CIMAH update is due. But some consultees said that this would bring forward the submission date earlier than required by the Directive which would be onerous because of the additional detailed information required by COMAH and that at least 15 months would be needed to assimilate the guidance and thus the earliest date that could be considered would be May/June 2000 others argued that no safety reports should be necessary before February 2001.
The Commission pointed out that the Seveso II Directive does not require submission before 3 February 2001 and some of the industry needed at least 15 months to assimilate guidance before they could submit reports to the relevant authorities. HSE officials reported that guidance on writing a COMAH safety report would be issued in March 1999. Although HSE acknowledged COMAH reports were more demanding than CIMAH reports, much of the detail necessary for COMAH reports would already be in the CIMAH reports. It was acknowledged that a log jam would be created if many safety reports were received together and this would cause a resourcing difficulty. The Commission agreed that the timetable for submission should be February 2000, and that where operators had a major problem submitting safety reports by that date, they should be allowed by way of exemption a further three months to allow them until May 2000. Operators however, should be encouraged to submit their reports as soon as practicable to avoid all reports being submitted together towards the end of the period.
Consultees considered that a significant change in the safety management systems at an establishment was an event that could have significant repercussions for the prevention of major accidents. A new regulation was therefore created which requires that, whenever the operator makes a change to the safety management system (as specified in Schedule 4 of COMAH), which has a significant repercussion with respect to the prevention and mitigation of major accidents, the operator must review their safety report
There should be a staggered approach to the review of safety reports. Consultees wanted to continue the CIMAH approach where safety reports could be submitted/reviewed in parts over a three year period. Each part would be reviewed at the required periodic interval.
HSE officials outlined the advantages and disadvantages of examining the whole safety report and the approach developed under CIMAH whereby an operator is able to submit/review its safety report in parts. The Commission strongly supported HSE adopting a suitable approach which could be either the full report or a staggered approach, and that the key element was to find a way of making it work. The Commission agreed a revised 8(3) and 17(2) allowing for the staggering of reviews of safety reports (on a five yearly cycle) with a holistic review of all parts after the final part was reviewed.
Health services felt that operators should consult with the local health authority on the on-site emergency plan.
The Regulations have been amended to include this, regulation 9(3)(d) added and associated guidance incorporated.
During the initial consultation exercise, a number of issues were raised, including: concern at the resource implications of making safety reports available at operator’s premises; many operator’s preferred safety reports to be kept at Agency offices and HSE public information points; there were fairly evenly balanced views on the need for a legal appeals mechanism for deciding issues of national security and commercial confidentiality. In light of these findings, and the general trend towards freedom of information, a further consultation exercise took place in December 1998. A number of changes to HSE’s original proposals were proposed, including: removal of the duty on operator’s to make available a safety report; certain information (e.g. notifications, safety reports etc) would be placed on a public register maintained by the competent authority and available for inspection by the public.
HSC noted the position on the provision of information on the public register. Information would not be disclosed where there was commercial confidential or national security implications. In addition consultees considered that there should be mechanisms to withhold information if it was ‘personally confidential’. The Commission noted that the public had the right to know about dangerous substances held at premises under reg 14 schedule 6. Information will be made available from the competent authority’s offices via public registers in a scheme similar to that used for Integrated Pollution Control. The regulations have been modified to make the disclosure of the inventory subject to the commercial confidentiality, national security and personal confidentiality safeguards. The Regulation has been transposed into a schedule (Schedule 8) to make it more "self standing" and easier to understand. Expanded guidance will indicate more clearly the types of information which can be withheld.
HSE, the Environment Agency (EA) and the Scottish Environment Protection Agency (SEPA), are required by Government to recover the costs of the regulatory activities that will fall to the competent authority under COMAH, through a charging regime.
Following consideration by Ministers, a new charging regulation (reg. 22) has been included in the COMAH Regulations. HSE, EA and SEPA, having examined the feasibility of various charging options concluded that a system of charging be introduced, calculated to recover the full costs of the time spent by the competent authority, for carrying out a relevant function for a particular establishment on any particular occasion or occasions. The costs will be calculated in accordance with Treasury’s Fees and Charges Guide. Further information on charging is available from the HSE website, and a guide describing the arrangements is also available.
HSE consulted further on a proposal to dis-apply PCA at COMAH sites, believing that the combination of controls on flammable substances in the Highly Flammable and Liquefied Petroleum Gases Regulations, supported by general health and safety legislation, were sufficient to regulate the safekeeping of petroleum at COMAH sites; and at sites subject to the Notification of Installations Handling Hazardous Substances Regulations 1982 (NIHHS). A clear majority of consultees were in favour of the disapplication of PCA in these circumstances.
Guidance to Schedule 2 should more clearly distinguish between what is required as a policy set out in a document and what is required in terms of a safety management system for implementing the policy. The status of the MAPP within the safety report also needs clarification.
The guidance will be more explicit on what format the MAPP can take. A free information sheet on MAPPs, targeted at lower tier sites is now available.
There was concern from industry about the amount of detail that would be required in safety reports. They also felt that there needed to be a greater degree of consistency between the guidance on the regulations and the SHARPP manual on the information to be included in the safety report. More was needed on the interface between the pre-construction part of the safety report and the hazardous substances consent process.
The guidance has been drawn widely so that the level of detail required in a safety report can be made proportionate to the level of hazard and risk. There is a specific paragraph on this point in the guidance on risk analysis and prevention methods. The consistency and interface points have been addressed in guidance. A hazardous substances consent can now legally form part of a safety report.
Industry wanted more information on assessment criteria which related specifically to the environment.
Additional guidance to be provided. The longer term aim is to integrate environmental and safety criteria wherever possible, although in the first instance separate guidance on environmental assessment criteria will be issued with integration taking place when they are revised.
There was general agreement that operators should decide whether a modification could have significant repercussions on major hazards and should therefore be notified to the competent authority, but there was some disagreement from industry with the examples given in the draft guidance. There was also concern from industry about possible delays in implementing modifications if it was dependent on the views of the competent authority.
The guidance examples have been qualified by a general paragraph which points to the degree of increase of risk. Guidance will emphasise that there is no legal obligation to wait for the competent authority’s view before making a modification but that it might be prudent to do so, particular where the changes are large scale.
There was very significant support for the need to avoid inconsistency and duplication and to streamline the approach to enforcement of COMAH and IPPC. However, there were some concerns from industry and local authorities whether this could be achieved in practice by the mechanism of a single competent authority comprising the environment agencies and HSE. All agreed that the channels of communication from the operator to the competent authority needed to be clear with a "one-stop shop" wherever possible, and the agencies and HSE needed to develop clear and detailed working arrangements through memoranda of understanding.
These needs are well recognised and memoranda of understanding have been developed which set out the responsibilities of HSE and the Agencies. More detailed working arrangements are being developed to build on this framework by a Steering Group on which there are representatives from all three parts of the competent authority. A fundamental principle underpinning the arrangements is clarity for operators in who they deal with.
Consultees said that there should be an interim off-site plan to cover the period before the COMAH off-site plan is in place.
This has been included in guidance.
Consultees wanted greater clarity on emergency plan testing; testing of on-site and off-site plans together; emergency planning for domino effects establishments and apportioning of costs for planning and testing at such establishments.
All these issues have been amplified in guidance.
There was no consensus between industry, local authorities and emergency services on the scope of charging for off-site emergency planning. COMAH allows emergency services to charge (indirectly via the local authority) operators when they participate in the testing of an off-site emergency plan but not when they help local authorities to prepare, review and revise off-site emergency plans because testing is the only new provision of COMAH not present in CIMAH. Local authorities and emergency services wish the emergency services to be able to recover their costs for assisting local authorities to prepare and review off-site emergency plans; industry was against this and opposed to local authorities and emergency services recovering their costs of testing off-site emergency plans.
This matter is being considered further.
DETR lead on this aspect of implementation and analysed the comments on land use planning. Consultees were supportive of the approach in the CD that the Planning Hazardous Substances Consent procedure should be used to give effect to these requirements, and they were taken into account in preparing amendments to the relevant planning legislation. Article 12 has been implemented by Town and Country Planning legislation, namely the Planning (Control of Major Accident Hazards) Regulations 1999. These are amending Regulations and amend: The Planning (Hazardous Substances) Act 1990; the Planning (Hazardous Substances) Regulations 1992; the Town and Country Planning (Development Planning) Regulations 1991; and, the Town and Country Planning (General Development Procedure) Order 1995.
These regulations have been largely superseded by subsequent legislation except for the issue of "temporary presence". NIHHS still requires notification of any activity involving dangerous substances (above prescribed thresholds) involving temporary presence. In practice this means road transport depots, rail marshalling yards and loading/unloading at docks. There was no consensus for revoking NIHHS or on how to take it forward (40% favoured revocation, 44% wanted to keep it in one form or another, and 16% favoured further study as part of HSE’s overall policy on the major hazards aspects of the transport of dangerous goods).
This matter is to be considered further, in the context of overall policy on major hazards aspects of the transport of dangerous goods. This does not affect COMAH.
There should be more references to the involvement of employees.
Guidance has been amended to include references to the vital role of employees and their representatives and the fact that COMAH requirements are in addition to more general legislation which ensures employee involvement.
Some consultees were concerned about the application of COMAH to explosives sites and the consequent requirement to produce safety reports which they considered unnecessary for sites holding a license under the Explosives Act.
COMAH will apply to a number of licensed explosives sites where quantities present exceed threshold values. Safety reports cover a significantly wider range of health and safety issues than are included in an explosive license. However, matters which are covered in an explosive license will not need to be duplicated in the COMAH safety report; they will simply need to be cross referenced. A pilot study will be carried out at two explosive sites. Among other aspects, this is expected to identify any significant issues arising in practice from the safety report/license interface. The outcomes from the pilot study will then be included in supplementary guidance that is planned to support the writing of safety reports for explosive sites.
Consultees, particularly from the storage and batch manufacturing sector, wanted it to be made clearer that they could provide information on generic categories of substances rather than named substances. They wanted the re-notification requirements to be triggered by substantial changes which would have a significant impact on hazard and risk.
Guidance has been amended to refer to operators who face frequent inventory fluctuations and who do not always have long notice of receipt of named substances. Guidance recommends that operators should plan on the basis of ceiling quantities of generic types of substances. They should consider application against these ceilings and then re-notify only if there are permanent changes in the type of quantity of dangerous substances. Also clarification that, in these circumstances, the operator must pitch their prevention and mitigation measures at the most hazardous substances they handle.
More guidance is needed on the circumstances whereby the competent authority might prohibit where they come across serious deficiencies.
Examples have been included in the guidance.